Device Classification Name |
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
|
510(k) Number |
K960738 |
Device Name |
STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) |
Applicant |
ENGINEERED CUSTOM MFG., INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657
|
|
Applicant Contact |
ALLAN FRIEZE |
Correspondent |
ENGINEERED CUSTOM MFG., INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657
|
|
Correspondent Contact |
Tania Lupu |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 02/23/1996 |
Decision Date | 05/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|